Method for reducing microbial load for individuals with elevated risk conditions

Abstract

A method for reducing risk of infection from microorganisms for certain elevated-risk individuals, includes: administering a barrier-forming composition in a therapeutically effective amount to a surface, the surface comprising a mucosa, or a mucosal or skin lesion of an individual. The individual has an elevated risk condition selected from: an elevated risk of being exposed to harmful viral, bacterial, or fungal microorganisms; a condition causing an elevated risk of infection from viral, bacterial, or fungal microorganisms; and an elevated risk of serious complications resulting from an infection caused by viral, bacterial, or fungal microorganisms. The method includes forming a barrier coating on the surface that is active to trap, and kill or neutralize microorganisms encountered by the barrier coating and effectively reducing the microbial load on the surface and continuing to administer the barrier-forming composition in a therapeutically effective amount to the surface, for one time or more in a 24 hour period.

It is claimed: 
     
         1 . A method for reducing risk of infection from microorganisms for certain elevated-risk individuals, the method comprising:
 administering a barrier-forming composition in a therapeutically effective amount to a surface, the surface comprising a mucosa, or a mucosal or skin lesion of an individual;   the individual having an elevated risk condition: the elevated risk condition being selected from the group consisting of: an elevated risk of being exposed to harmful viral, bacterial, or fungal microorganisms; a condition causing an elevated risk of infection from viral, bacterial, or fungal microorganisms; and an elevated risk of serious complications resulting from an infection caused by viral, bacterial, or fungal microorganisms;   forming a barrier coating on the surface that is active to trap, and kill or neutralize microorganisms encountered by the barrier coating and effectively reducing the microbial load on the surface;   continuing to administer the barrier-forming composition in a therapeutically effective amount to the surface, for one time or more in a 24 hour period.   
     
     
         2 . The method of  claim 1 , wherein the barrier coating is active to trap, and kill or neutralize microorganisms encountered by the barrier coating for a duration of at least one hour. 
     
     
         3 . The method of  claim 1 , wherein the individual has the elevated risk of being exposed to harmful viral, bacterial, or fungal microorganisms due to the individual living or working on an airplane, train, bus, ship, boat, in a school, a library, a dormitory, a hotel, an apartment building, a courthouse, a correctional facility, an airport, a restaurant, a movie theater, a theater, a mall, a retail establishment, a special event arena, a special event stadium, a religious gathering place, a nursing home, hospital, other health-care facility, an office, or day-care facility. 
     
     
         4 . The method of  claim 1 , wherein the individual has the condition causing an elevated risk of infection from viral, bacterial, or fungal microorganisms; the condition being one or more selected from the group consisting of: having received an organ or bone marrow transplant, having received a skin graft, having undergone surgery within 30 days, undergoing ventilator treatments, HIV and AIDS, cancer, auto-immune disease, diabetes, conditions that cause lesions on the skin or mucosa, and having lesions on the skin or mucosa. 
     
     
         5 . The method of  claim 1 , wherein the individual has the elevated risk of serious complications resulting from an infection caused by viral, bacterial, or fungal microorganisms, the elevated risk being due to at least one condition selected from the group consisting of: being immunocompromised, having received an organ or bone marrow transplant, having received a skin graft, undergoing chronic steroid treatment, being under 19 and undergoing long-term aspirin treatment, being morbidly obese, being pregnant, being 65 years of age or older, children younger than two years of age, HIV, AIDS, cancer, metabolic disorder, mitochondrial disorder, liver disorder, kidney disorder, asthma, blood disorders, endocrine disorders, heart disease, chronic lung disease, cerebral palsy, epilepsy, stroke, muscular dystrophy, and spinal cord injury. 
     
     
         6 . The method of  claim 1 , further comprising, administering a therapeutically effective amount of the barrier-forming composition every about two to about twelve hours to the surface. 
     
     
         7 . The method of  claim 1 , further comprising, administering a therapeutically effective amount of the barrier-forming composition one more times in a 24 hour period for five 24 hour periods or more. 
     
     
         8 . The method of  claim 1 , further comprising, administering a therapeutically effective amount of the barrier-forming composition three or more times in a 24 hour period for five 24 hour periods or more. 
     
     
         9 . The method of  claim 1 , wherein the barrier-forming composition comprises a humectant, an antimicrobial, and optionally a gum, wherein the gum, if present, is present in an amount of about 0.01% to about 0.4% by weight of the total barrier-forming composition. 
     
     
         10 . The method of  claim 1 , wherein the barrier-forming composition meets the following requirements:
 about 0.0001%≦C≦about 0.4%;   about 0.07%≦H≦about 70%; and   0.0005%<A or   about 0%≦C≦about 0.4%;   about 55%≦H≦about 70%; and   0.0005%<A   wherein all percentages are by weight of the total composition;   
       wherein C is a carbohydrate gum; H is a humectant; and A is the antimicrobial agent. 
     
     
         11 . The method of  claim 1 , wherein the antimicrobial agent is a monoquaternary ammonium compound. 
     
     
         12 . The method of  claim 1 , further comprising:
 wherein the step of administering the barrier-forming composition occurs in response to:   a. identifying a contaminated environment that the individual with the elevated risk condition is present in or is going to be present in, wherein the contaminated environment is known or expected to be contaminated with harmful viral, fungal, or bacterial microorganisms; or   b. observing a contamination event in an environment wherein the individual with the elevated risk condition is present in the environment or is going to be present in the environment;   
     
     
         13 . The method of  claim 1 , wherein the barrier-forming composition has a viscosity of less than 500 cps. 
     
     
         14 . The method of  claim 1 , wherein the therapeutically effective amount of the barrier-forming composition is non-toxic for human consumption. 
     
     
         15 . The method of  claim 1 , wherein the barrier layer has antimicrobial cidal or static activity for a duration of about six to about twenty-four hours. 
     
     
         16 . The method of  claim 1 , wherein the barrier-forming composition is applied by spraying. 
     
     
         17 . The method of  claim 1 , wherein the barrier-forming composition is applied by a roll-on applicator or a treated wipe. 
     
     
         18 . The method of  claim 1 , further comprising administering the barrier-forming composition every day at least three times a day. 
     
     
         19 . The method of  claim 1 , wherein the microorganisms are selected from the group consisting of:  Candida, Pneumonia , MRSA,  Streptococcus, P. gingivalis, S. pyogenes, S. pneumonia, S. mutans, S. aureus, Y. enterocolitica, Acinetobacter bumanii, Streptococcus sanguis, S. oralis, S. mitis, S. salivarius, S. gordonii, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum, C. albicans, C. krusei, C. tropicalis, C. glabrata , microorganisms that cause upper respiratory infections, HIV, EBV, and influenza viruses. 
     
     
         20 . The method of  claim 1 , wherein the microorganisms are selected from the group consisting of:  Candida, Pneumonia , MRSA,  Streptococcus, P. gingivalis, S. pyogenes, S. pneumonia, S. mutans, S. aureus, Y. enterocolitica, Acinetobacter bumanii, Streptococcus sanguis, S. oralis, S. mitis, S. salivarius, S. gordonii, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum, C. albicans, C. krusei, C. tropicalis, C. glabrata , HIV, EBV, influenza viruses, microorganisms that cause upper respiratory infections,  Centipeda periodontii, Eikenella corrodens , Enterobacteriaceae,  Fusobacterium nucleatum  subsp.  nucleatum, Fusobacterium nucleatum  subsp.  polymorphum, Fusobacterium nucleatum  subsp.  vincentii, Fusobacterium periodonticum, Porphyromonas endodontalis, Prevotella  ( Bacteroides )  melaminogenica, Prevotella intermedia, Bacteroides  ( Bacteroides )  loescheii, Solobacterium moorei, Tannerella forsythia  ( Bacteroides forsythus ),  Treponema denticola, Clostridium difficile, Bordetella pertussis, Burkholderia, Aspergillus fumigatus, Penicillium  spp,  Cladosporium , HPV, cold,  Klebsiella pneumoniae, Salmonella choleraesuis, Escherichia coli  (0157:H7),  Trichophyton mentagrophytes , Rhinovirus Type 39, Respiratory Syncytial Virus, Poliovirus Type 1, Rotavirus Wa, Influenza A Virus, Herpes Simplex Virus Types 1 & 2, and Hepatitis A Virus. 
     
     
         21 . The method of  claim 1 , wherein the antimicrobial agent is a monoquaternary ammonium compound. 
     
     
         22 . The method of  claim 1 , wherein the antimicrobial agent is exclusive of fatty acid ethers or esters of polyhydric alcohols or alkoxylated derivatives thereof. 
     
     
         23 . The method of  claim 1 , wherein there is about 50% to about 99% reduction of the microbial burden from about one to about six hours after the administering step. 
     
     
         24 . The method of  claim 1 , wherein the mucosa is an oral, nasal, or pharyngeal mucosa. 
     
     
         25 . A method for reducing the microbial load in immunocompromised individuals, the method comprising:
 administering a barrier-forming composition that comprises an antimicrobial to a surface, the surface comprising an oral, nasal, or pharyngeal mucosa or a skin lesion of an immunocompromised individual;   forming a barrier coating on the surface that is active to trap, and kill or neutralize microorganisms encountered by the barrier coating for a duration of at least about one hour, thereby effectively reducing the microbial load of the surface;   wherein the barrier-forming composition meets the following requirements:   about 0.0001%≦C≦about 0.4%;   about 0.07%≦H≦about 70%; and   0.0005%<A or   about 0%≦C≦about 0.4%;   about 55%≦H≦about 70%; and   0.0005%<A   wherein all percentages are by weight of the total composition;   wherein C is the carbohydrate gum; H is the humectant; and A is the antimicrobial agent.   
     
     
         26 . The method of  claim 25 , wherein the barrier-forming composition has antimicrobial cidal or static activity for a duration of about six to about twenty-four hours. 
     
     
         27 . The method of  claim 25 , wherein the barrier-forming composition has a viscosity of less than 500 cps. 
     
     
         28 . The method of  claim 25 , further comprising continuing to administer the barrier-forming composition in a therapeutically effective amount to the surface, for one time or more in a 24 hour period. 
     
     
         29 . The method of  claim 25 , wherein there is about 50% to about 99% reduction of the microbial burden from about one to about six hours after the administering step.